Independent Quality / Compliance / Technical Consultant to Biopharmaceutical clients. Biopharmaceutical Quality and Compliance Consultant / Contractor supporting the product owner and third party manufacturing and laboratory pre-approval inspection preparation (readiness) for licensing and registration submissions in US and RoW markets. Primary focus areas have been the establishment of standardized quality agreements (with Contract Manufacturers, Laboratories, Packaging, Storage Centers and Logistics and Distributions Centers) and Deviation / CAPA evaluations and implementations.